Study Stopped
terminated due to low enrollment rate
The Chimerix CMX001 Registry
CMX001
A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.
1 other identifier
observational
550
3 countries
51
Brief Summary
The prospective observational study is to establish a registry database to evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s well as survival rates in subjects previously enrolled in selected clinical studies of CMX001. Each Registry participant will be followed for a period of approximately 3 years from their enrollment in the Registry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
Longer than P75 for all trials
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2019
CompletedMay 17, 2019
May 1, 2019
5.4 years
June 17, 2014
May 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Time to all-cause mortality
evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as the development of new malignancies and late cytomegalovirus (CMV)-associated events, as well as survival rates in subjects previously enrolled in selected clinical studies of CMX001
10 years
Study Arms (1)
CMX001
Subjects who have previously participated in CMX001-301 or other CMX001 study.
Interventions
Eligibility Criteria
Subjects previously enrolled in selected clinical studies of CMX001
You may qualify if:
- Have previously completed study CMX001-301 through the Week 24 visit, or participated in another qualifying clinical study with CMX001.
- Willing and able to understand and provide written informed consent to participate in this observational study
- Willing and able to participate in all required study activities for the entire duration of the observational study (i.e., agreeable to being contacted at periodic intervals over the course of approximately 10 years following the completion of study CMX001-301 or other qualifying clinical study.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
University of California San Diego
La Jolla, California, 92093, United States
St. Vincent Medical Center
Los Angeles, California, 90006, United States
Children's Hospital of LA
Los Angeles, California, 90027, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Stanford University
Palo Alto, California, 94305, United States
Childrens Hospital of Colorado
Aurora, Colorado, 80045, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
University of Colorado Hospital/Health Science Center
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06519, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Miami
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30306, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, 30306, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwestern University School of Medicine
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118, United States
Johns Hopkins University
Baltimore, Maryland, 44195, United States
Brigham and Women's Hospital/Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Harper University Hospital
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Children Mercy Hospital and Clinics
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Hackensack
Hackensack, New Jersey, 07601, United States
Mt Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weil Cornell Medical Center
New York, New York, 10065, United States
Albert Einstein Cancer Center at Montefiore Medical Park
The Bronx, New York, 10467, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University
Durham, North Carolina, 27710, United States
Wake Forest University Baptist Center
Winston-Salem, North Carolina, 27517, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229, United States
Oncology Hematology Care, Inc
Cincinnati, Ohio, 45242, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Allegheny-Singer Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
St. Judes Children's Hospital
Memphis, Tennessee, 38105, United States
Baylor Cancer Center
Dallas, Texas, 75246, United States
University of Texas-MD Anderson
Houston, Texas, 77030, United States
Methodist Healthcare System
San Antonio, Texas, 78229, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Utah
Salt Lake City, Utah, 84113, United States
Intermountain Center for Hematological Malignancies
Salt Lake City, Utah, 84143, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Centre Hospitalier Unversitaire Sart
Liège, Belgium
University of Toronto
Toronto, Ontario, M5G 2C4, Canada
Hopital Maisonneuve-Rosement
Montreal, Quebec, H1T 2M4, Canada
MeSH Terms
Interventions
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 19, 2014
Study Start
January 1, 2014
Primary Completion
May 10, 2019
Study Completion
May 10, 2019
Last Updated
May 17, 2019
Record last verified: 2019-05